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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Until the new regulation comes into force, authorisation of clinical trials is regulated by Legislative Decree 211/2004, as amended. This is a two-step procedure, in which the two phases run in parallel. The competent authority for all clinical trials from Phases I to IV is the Italian Medicines Agency (AIFA), which retains vetting power for 60 days from notification. Documents must comply with the requirements established in the Ministerial Decree of December 21 2007 and be submitted through the National Monitoring Centre of Clinical Trials’ database.
At the local level, the trial must be authorised by the competent ethics committee for each trial site.
How robust are the standard good clinical practices followed in your jurisdiction?
The AIFA, the competent authority for enforcement actions in clinical trials, conducts thorough trial site inspections, including inspections of aspects relating to the implementation of and compliance with the good clinical practices.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The Ministerial Decrees of May 12 2006 and February 8 2013 concerning the requirements of ethics committees state that a trial’s protocol must guarantee the investigators’ right to disseminate and publish the results without prejudicing the confidential information and data protection provisions. The protocol must also expressly set out the sponsor’s commitment to publishing the trial results, regardless of whether they are positive.
Similarly, clinical trial agreements usually contain provisions that allow investigators to publish data that they have collected from a site if, after a certain period (usually between one to two years from the study’s conclusion), the sponsor has not done so in full.
The AIFA shares the European Medicines Agency’s policy on the transparency and disclosure of clinical trial data contained in the marketing authorisation dossier once the product has been authorised.
What are the informed consent obligations with respect to clinical trial subjects?
Clinical trial subjects must be given full, thorough and clear information about the trial in order to assess the risks and benefits of their participation. The language must be relatively easy for a layperson to understand and the subject must be given extensive time to consider the trial and seek any necessary clarifications or assurances.
To obtain informed consent, subjects must receive all potentially relevant information, including with regard to:
- the benefits and risks of the treatment;
- how their confidentiality and privacy will be protected;
- how their biological samples will be used, stored and destroyed;
- insurance coverage;
- their right to withdraw from the study; and
- the consequences in terms of the data and samples collected.
In case of minors or incapacitated persons, consent must be given by an authorised representative.
What are the insurance requirements for clinical trials?
Insurance requirements are set out in the Ministerial Decree of July 14 2009. Insurance must cover the civil liability of all subjects involved in the clinical trial – as well as that of the sponsor, site and investigator – for any damage suffered by subjects arising from the study. In particular, insurance must cover damages (eg, death and injury, as well as direct economic loss) arising from negligence or professional misconduct on the part of the investigator, as well as any unintentional damages that the investigator may cause.
The maximum coverage should be no less than €1 million for each trial subject and no less than the prescribed thresholds for each clinical trial protocol, depending on the number of enrolled patients.
If the insurance policy provides for a franchise, it cannot be enforced against the trial subject.
What data protection issues should be considered when conducting clinical trials?
In 2008 the Data Protection Authority clarified by way of its Guidelines on Clinical Trials that trial patients’ coded data is not anonymous. Rather, it is ‘de-identified’ data as, in exceptional circumstances, the sponsor can undertake a re-identification process. Therefore, the sponsor and clinical trial site are both considered to be data co-holders, while the contract research organisation and the investigator act are data processors.
Specific information must be provided where genetic data will be processed.
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